Hemispherx plant in New Brunswick New Jersey set for pre approval inspection this year

Production of wart drug with anti Ebola potential set to restart in New Jersey

05-Mar-2015 - Hemispherx will make a candidate Ebola treatment being trialled by the US military at its revamped plant in New Jersey.

Blood cancer: a $24bn business (Image: Christaras A)

AbbVie buys Pharmacyclics, bags Imbruvica blood cancer blockbuster

05-Mar-2015 - AbbVie is set to buy Californian small-molecule maker Pharmacyclics for $21bn (€19bn), cementing its haematology-oncology business.

Irix Pharmaceutical facility in Greenvill to be acquired by Patheon in takeover deal

Patheon: Irix deal about US and Canadian customer demand for local APIs; all staff to be retained

05-Mar-2015 - Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.

EDQM calls on Telangana based suppliers to update CEP details

Hundreds of API suppliers with plants in new Indian state Telangana need to update EDQM

04-Mar-2015 - As many as 450 API and intermediate suppliers in India's newest State - Telangana – need to log their changed addresses with the EDQM before August.

Health Canada looks to crack down further on noncompliant manufacturers

Health Canada looks to crack down further on noncompliant manufacturers

04-Mar-2015 - Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.

SEC calls on pharma companies to be more forthcoming with FDA disclosures

SEC calls on pharma companies to be more forthcoming with FDA disclosures

04-Mar-2015 - The SEC’s enforcement director is calling out pharma companies for failing to disclose and misinforming investors about correspondence with the US FDA.  

Irix facility in Greenville, South Carolina, US

Patheon has bought hard-to-make API specialist Irix Pharmaceuticals

04-Mar-2015 - Patheon has bought hard-to-manufacture active pharmaceutical ingredient (API) specialist, Irix Pharmaceuticals.

Testosterone: older men may have low levels, but current therapies are not approved for them, says FDA

Testosterone-makers must conduct cardio clinical trial, US FDA orders

04-Mar-2015 - The US Food and Drug Administration (FDA) has ordered makers of testosterone therapies to change their labelling and conduct clinical trials to investigate heart attack and stroke risk.

Existing KVK Tech plant to be retained

US defence cuts an opportunity for generics firm KVK Tech

04-Mar-2015 - US fighter jet firm Lockheed Martin has agreed to sell a satellite production plant in Newtown, Pennsylvania to drugmaker KVK-Tech.

Research at AstraZeneca's site in Boston, MA

AZ spins out antibiotics R&D biz to focus on key pipelines

04-Mar-2015 - AstraZeneca will spend $40m spinning out its antibiotics R&D business into a separate subsidiary, saying the move will let it focus on its core disease areas.

Poppy plant and pod

Sun Pharma goes after opiates with deal to buy GSK’s Aus business

03-Mar-2015 - Indian giant Sun Pharma has bought GSK’s Australian Opiates business.

US Biosimilars market still some way away despite recent regulatory progress, analysts

Regulations not the only barrier to biosimilars in the US say analysts

03-Mar-2015 - A robust US biosimilars market is still some way off according to analysts who say interchangability, doctors’ safety concerns and patient demands should be considered alongside the regulatory environment by firms mulling entry.

A diabetes pen next to a traditional syringe. (Image: Blausen staff)

US FDA labelling change to all diabetes pens to prevent HIV risk

03-Mar-2015 - The US FDA is requiring manufacturers to place label warnings on all multi-dose diabetes pens as patients continue to share the devices.

Med Prep Consulting execs may face gaol over sterility problems at plant in Tinton Falls, New Jersey

Med Prep execs accused of lying about sterility practices at compounding facility

02-Mar-2015 - Med Prep Consulting execs committed fraud and violated the Federal Food, Drug and Cosmetic Act (FDCA) according to the US DoJ, which has accused the New Jersey compounder of knowingly selling drugs produced in unsanitary conditions.

3D printing firm buys old, new Forest plant

3D pill printing firm Aprecia leases Forest Labs site as production hub

02-Mar-2015 - 3D drug printing firm Aprecia Pharmaceutical has leased an old Forest Labs facility sold following the firm’s $28bn takeover by Actavis last year.

Pharma's biggest movers

Pharma's biggest movers

02-Mar-2015 -

Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

27-Feb-2015 - The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publicly accessible database of clinical trial data does not do enough to make the data transparent. 

Tokyo, Japan

Novartis ordered to halt drug production in Japan for 15 days

27-Feb-2015 - Novartis’s Japanese unit has been ordered to temporarily halt production of drugs by Japan’s health Ministry as punishment for delayed reporting of side effects.

Heptares talks Sosei takeover

Sosei, so good: Heptares' collaborations to continue post takeover

26-Feb-2015 - Sosei's takeover will not impact Heptares's antibody tech collaboration with Morphosys according to the UK membrane protein specialist.

Valeant's CEO says gastrointestinal indications are underserved. (Image: Robert McDonald)

Salix latest purchase by Valeant after Dendreon deal

26-Feb-2015 - Valeant has signed a $14.5bn deal to acquire GI drugmaker Salix days after agreeing to purchase Provenge-maker Dendreon.